SALICOV: Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva
Study Details
Study Description
Brief Summary
The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Containment of the COVID19 pandemic relies on mass screening to allow rapid identification and isolation of cases to break transmission chains. The reference diagnostic method is based on detection of viral genomes by PCR on a nasopharyngeal swab sample (NPS).
However, the pandemic has generated a very high demand causing a shortage of specific swabs and difficulties in the supply of reagents and consumables. Nasopharyngeal sampling requires skilled personnel, and is sometimes poorly accepted by patients. These issues can reduce the quality of sampling and therefore the sensitivity of the test. This strategy also requires sending samples to specialized laboratories, generating a delay in providing results.
New diagnostic approaches on saliva samples are being developed allowing 1) an easier sampling procedure and 2) a diagnostic technique that can be performed in point-of-care.
Previous evaluations suggest that these approaches have a lower sensitivity than the reference strategy (PCR on NPS), around 50 to 90% depending on the technique used.
Despite lower sensitivity compared to the reference strategy, the investigators hypothesize that detection of SARS-CoV2 on saliva samples will improve the performance of the screening program by considerably increasing the number of individuals tested in shorter times.
The main objective of the study is to evaluate, for the detection of SARS-CoV-2 infection, the performance of various alternative virological diagnostic strategies on saliva samples, in comparison with the reference technique (RT-PCR on NPS).
The primary endpoint of the study is positivity of the standard technique (RT-PCR on NPS) for the SARS-CoV-2 virus. The result of the alternative strategies on a saliva sample will be considered as positive or negative according to criteria specific to each of them and compared to the result of the reference technique to estimate their respective sensitivity.
The secondary objectives are to compare the diagnostic performances of RT-PCR on saliva versus RT-PCR on NPS, the diagnostic performances of alternative techniques on saliva versus RT-PCR on saliva, to evaluate the acceptability of the saliva self-sampling and the cost-effectiveness of new diagnostic strategies compared to the reference technique.
The study will include adults and children in whom a NPS is performed for SARS-CoV-2 screening. After informed consent, participants will be asked to provide a saliva sample before nasopharyngeal sampling. Both samples will be analyzed in parallel. The analytical performance of each technique will be assessed, centrally or delocalised, depending on the feasibility of the techniques and according to the advice of the scientific board. The analyzes will be carried out by a team of technicians specifically recruited for the study. All samples collected will be stored in a centralized in a biobank.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Salicov Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab |
Diagnostic Test: Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test
Diagnostic Test: Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
Diagnostic Test: axillary sweat sample
Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.
Other: Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
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| SalicovII (ancillary study) Ancillar study : Children and teachers / staff from middle and high schools in Ile de France Saliva samples is collected as part of care. Only a self-rated questionnaire is collected. |
Diagnostic Test: Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
Other: Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
|
Outcome Measures
Primary Outcome Measures
- Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus [At diagnosis]
RT-PCR on nasopharyngeal is considered as gold standard
Secondary Outcome Measures
- Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus [At diagnosis]
- Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus [At diagnosis]
- Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus [At diagnosis]
- Practicability to samples [At diagnosis]
Number of samples tested in a day for each test
- Practicability to premises [At diagnosis]
Quantity of premises required for each test
- Practicability to interpretation [At diagnosis]
Feasibly Reading and interpretation For each test
- Practicability to render time [At diagnosis]
Render times for each test
- IgG Antibody detection in saliva [At diagnosis]
Research of IgG by ELISA and RDT
- IgM Antibody detection in saliva [At diagnosis]
Research of IgM by ELISA and RDT
- IgA Antibody detection in saliva [At diagnosis]
Research of IgA by ELISA and RDT
- Positivity of canine olfactory detection of SARS-CoV-2 [At diagnosis]
- Patient tolerance of the salivary self-sampling [At diagnosis]
Evaluation by questionnaire of the patient tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions are about pain, discomfort, speed of performance)
- Operator tolerance of the salivary self-sampling [At diagnosis]
Evaluation by questionnaire of the operator tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions is about pain, discomfort, speed of performance)
- Cost of each approach [At diagnosis]
Including sampling, transport, technique (consumables, reagents, machine), human resources
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult or child subject able to receive nasopharyngeal swab, regardless of age
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Subject in whom nasopharyngeal swab is performed for detection of SARS-CoV-2 as part of the screening system managed by APHP
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Subject or parent not opposed to saliva sampling and data collection as part of this research
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SARS-CoV-2 screening device of Assistance Publique des Hôpitaux de Paris (AP-HP) | Paris | France | 75001 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Study Director: Jérôme Le Goff, Professor, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
- Angle C, Waggoner LP, Ferrando A, Haney P, Passler T. Canine Detection of the Volatilome: A Review of Implications for Pathogen and Disease Detection. Front Vet Sci. 2016 Jun 24;3:47. doi: 10.3389/fvets.2016.00047. eCollection 2016.
- Azzi L, Baj A, Alberio T, Lualdi M, Veronesi G, Carcano G, Ageno W, Gambarini C, Maffioli L, Saverio SD, Gasperina DD, Genoni AP, Premi E, Donati S, Azzolini C, Grandi AM, Dentali F, Tangianu F, Sessa F, Maurino V, Tettamanti L, Siracusa C, Vigezzi A, Monti E, Iori V, Iovino D, Ietto G; ASST dei Sette Laghi Rapid Salivary Test Nurse staff Research Group, Grossi PA, Tagliabue A, Fasano M. Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study. J Infect. 2020 Sep;81(3):e75-e78. doi: 10.1016/j.jinf.2020.06.042. Epub 2020 Jun 21.
- Chen JH, Yip CC, Poon RW, Chan KH, Cheng VC, Hung IF, Chan JF, Yuen KY, To KK. Evaluating the use of posterior oropharyngeal saliva in a point-of-care assay for the detection of SARS-CoV-2. Emerg Microbes Infect. 2020 Dec;9(1):1356-1359. doi: 10.1080/22221751.2020.1775133.
- Grandjean D, Sarkis R, Lecoq-Julien C, Benard A, Roger V, Levesque E, Bernes-Luciani E, Maestracci B, Morvan P, Gully E, Berceau-Falancourt D, Haufstater P, Herin G, Cabrera J, Muzzin Q, Gallet C, Bacqué H, Broc JM, Thomas L, Lichaa A, Moujaes G, Saliba M, Kuhn A, Galey M, Berthail B, Lapeyre L, Capelli A, Renault S, Bachir K, Kovinger A, Comas E, Stainmesse A, Etienne E, Voeltzel S, Mansouri S, Berceau-Falancourt M, Dami A, Charlet L, Ruau E, Issa M, Grenet C, Billy C, Tourtier JP, Desquilbet L. Can the detection dog alert on COVID-19 positive persons by sniffing axillary sweat samples? A proof-of-concept study. PLoS One. 2020 Dec 10;15(12):e0243122. doi: 10.1371/journal.pone.0243122. eCollection 2020.
- Jamal AJ, Mozafarihashjin M, Coomes E, Powis J, Li AX, Paterson A, Anceva-Sami S, Barati S, Crowl G, Faheem A, Farooqi L, Khan S, Prost K, Poutanen S, Taylor M, Yip L, Zhong XZ, McGeer AJ, Mubareka S; Toronto Invasive Bacterial Diseases Network COVID-19 Investigators. Sensitivity of Nasopharyngeal Swabs and Saliva for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2. Clin Infect Dis. 2021 Mar 15;72(6):1064-1066. doi: 10.1093/cid/ciaa848.
- Jendrny P, Schulz C, Twele F, Meller S, von Köckritz-Blickwede M, Osterhaus ADME, Ebbers J, Pilchová V, Pink I, Welte T, Manns MP, Fathi A, Ernst C, Addo MM, Schalke E, Volk HA. Scent dog identification of samples from COVID-19 patients - a pilot study. BMC Infect Dis. 2020 Jul 23;20(1):536. doi: 10.1186/s12879-020-05281-3.
- Lai CKC, Chen Z, Lui G, Ling L, Li T, Wong MCS, Ng RWY, Tso EYK, Ho T, Fung KSC, Ng ST, Wong BKC, Boon SS, Hui DSC, Chan PKS. Prospective Study Comparing Deep Throat Saliva With Other Respiratory Tract Specimens in the Diagnosis of Novel Coronavirus Disease 2019. J Infect Dis. 2020 Oct 13;222(10):1612-1619. doi: 10.1093/infdis/jiaa487.
- Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, Le Goff J, Delaugerre C. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020 Jul 23;58(8). pii: e00977-20. doi: 10.1128/JCM.00977-20. Print 2020 Jul 23.
- Landry ML, Criscuolo J, Peaper DR. Challenges in use of saliva for detection of SARS CoV-2 RNA in symptomatic outpatients. J Clin Virol. 2020 Sep;130:104567. doi: 10.1016/j.jcv.2020.104567. Epub 2020 Jul 31.
- McCormick-Baw C, Morgan K, Gaffney D, Cazares Y, Jaworski K, Byrd A, Molberg K, Cavuoti D. Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8). pii: e01109-20. doi: 10.1128/JCM.01109-20. Print 2020 Jul 23.
- Migueres M, Mengelle C, Dimeglio C, Didier A, Alvarez M, Delobel P, Mansuy JM, Izopet J. Saliva sampling for diagnosing SARS-CoV-2 infections in symptomatic patients and asymptomatic carriers. J Clin Virol. 2020 Sep;130:104580. doi: 10.1016/j.jcv.2020.104580. Epub 2020 Aug 5.
- Rao M, Rashid FA, Sabri FSAH, Jamil NN, Zain R, Hashim R, Amran F, Kok HT, Samad MAA, Ahmad N. Comparing Nasopharyngeal Swab and Early Morning Saliva for the Identification of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2021 May 4;72(9):e352-e356. doi: 10.1093/cid/ciaa1156.
- To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
- To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149.
- Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a Noninvasive Specimen for Detection of SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8). pii: e00776-20. doi: 10.1128/JCM.00776-20. Print 2020 Jul 23.
- APHP200960
- 2020-A02431-38